(143 days)
The Nurochek-Pro System is intended for prescription use in healthcare facilities for subjects aged between 12 and 44 years old. for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment.
The Nurochek-Pro System is indicated for the generation of visual evoked potentials (VEP) and to acquire, transmit, display, and store electroencephalograms (EEG) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain iniury (mTBI) in subjects aged between 12 and 44 years old who have sustained a potential head injury in the past 120 hours (5 days).
The Nurochek-Pro System is a portable system designed to generate visual evoked potentials (VEPs) in patients and acquire, transmit, display, and store the resulting electroencephalogram (EEG). It is intended for prescription use in healthcare facilities, by healthcare professionals, on subjects aged between 12 and 44 years old, to aid in the diagnosis of mild traumatic brain injury (mTBI). The primary components of the Nurochek-Pro System are the wearable headset, the Nurochek-Pro Software Application, and the Nurochek-Pro Server.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (Nurochek-Pro System) |
|---|---|
| Sensitivity | 0.8551 (85.51%) with a 95% confidence interval of (0.7496, 0.9283) |
| Specificity | 0.6705 (67.05%) with a 95% confidence interval of (0.5621, 0.7670) |
| Positive Predictive Value (PPV) | 67.0% |
| Negative Predictive Value (NPV) | 85.5% |
| Ability to differentiate between subjects with and without mTBI | "The study demonstrated that the device can differentiate between subjects with and without mTBI." |
Study Details
-
Sample size used for the test set and data provenance:
- Sample Size: 157 individual steady-state visual-evoked potential (SSVEP) readings.
- Data Provenance: Not explicitly stated, but the study involved "study subjects (age range 12-49 years)" and the clinical research protocol required readings to be collected within 120 hours of suspected head injury, in addition to a clinical evaluation by a licensed physician. This suggests prospective data collection in a clinical setting. The manufacturer is Headsafe MFG Pty Ltd. in Australia, which may imply data origin.
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Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of Experts: Not explicitly stated as a specific number. However, the ground truth was established by "Each highly trained physician". This implies multiple physicians were involved.
- Qualifications of Experts: "highly trained physician" who used "their education and experience to deliver their mTBI determination." This likely includes neurologists or emergency medicine physicians, given the context of mTBI diagnosis.
-
Adjudication method for the test set:
- Adjudication Method: Not explicitly stated if a formal adjudication method (like 2+1 or 3+1) was used. The text mentions "Each highly trained physician used their education and experience to deliver their mTBI determination." This suggests individual clinical determination, but not necessarily a consensus or tie-breaking process.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: Not explicitly stated that an MRMC comparative effectiveness study was conducted involving human readers with and without AI assistance. The study described focuses on the device's standalone performance against clinical diagnosis.
- Effect Size: Therefore, no effect size for human reader improvement with AI assistance is provided.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the described performance (Sensitivity, Specificity, PPV, NPV) represents the standalone performance of the Nurochek-Pro System's classification algorithm. The clinical investigation aimed to "evaluate the performance of the Nurochek-Pro System against clinical diagnosis."
-
The type of ground truth used:
- Ground Truth Type: Clinical diagnosis by a licensed healthcare professional. This diagnosis was based on "a neurological examination, a concussion-related signs and symptom evaluation, and a review of all relevant information provided by the study subject in relation to their injury."
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The sample size for the training set:
- Sample Size: 272 individual steady-state visual-evoked potential (SSVEP) readings.
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How the ground truth for the training set was established:
- Training Set Ground Truth: The text states, "The Headsafe classification Algorithm used in this device was generated with 272 individual steady-state visual-evoked potential (SSVEP) readings, in which there was a 24.6% prevalence of mTBI." While not explicitly detailed for the training set ground truth establishment, it can be inferred that a similar process involving clinical evaluation by licensed physicians (as described for the validation set) was used to establish the mTBI status for the cases used to generate the algorithm. The "clinical research protocol required readings to be collected within 120 hours of the suspected head injury, in addition to a clinical evaluation by a licensed physician" applies to the study subjects from which the database was generated.
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March 27, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Headsafe MFG Pty Ltd. % Erin Gontang, Ph.D. Senior Consultant ROM+ 2790 Mosside Blvd., Suite 800 Monroeville, Pennsylvania 15146
Re: K243426
Trade/Device Name: Nurochek-Pro System Regulation Number: 21 CFR 882.1450 Regulation Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Regulatory Class: Class II Product Code: PIW, OMC Dated: February 25, 2025 Received: February 25, 2025
Dear Erin Gontang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Patrick Antkowiak -S" in a simple, sans-serif font. The name is stacked vertically, with "Patrick" on top and "Antkowiak -S" below it. To the left of the name is a faded FDA logo.
For Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Nurochek-Pro System
Indications for Use (Describe)
The Nurochek-Pro System is intended for prescription use in healthcare facilities for subjects aged between 12 and 44 years old. for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment.
The Nurochek-Pro System is indicated for the generation of visual evoked potentials (VEP) and to acquire, transmit, display, and store electroencephalograms (EEG) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain iniury (mTBI) in subjects aged between 12 and 44 years old who have sustained a potential head injury in the past 120 hours (5 days).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Headsafe. The logo consists of a green icon on the left and the word "HEADSAFE" in dark gray on the right. The icon is a combination of a gauge and a profile of a head. The gauge is green and has a needle pointing to the right. The head profile is also green and is facing to the right.
510(k) Summary
DATE PREPARED
March 27, 2025
MANUFACTURER AND 510(k) OWNER
Headsafe MFG Pty Ltd. 61 Marlborough Street, Suite 76 Surry Hills NSW 2010 Australia Telephone: +61 418 25 3333 Official Contact: Adrian Cohen, MD, CEO
REPRESENTATIVE/CONSULTANT
Erin A. Gontang, PhD RQM+ +1 (412) 899-7422 Telephone: Email: egontang@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Nurochek-Pro System |
|---|---|
| Common Name: | Brain injury adjunctive interpretive electroencephalographassessment aid |
| Regulation Number: | 21 CFR 882.1450 |
| Class: | II |
| Product Code: | PIW, OMC |
| Premarket Review: | Neurosurgical, Neurointerventional and NeurodiagnosticDevices (DHT5A) |
| Review Panel: | Neurology |
PREDICATE DEVICE IDENTIFICATION
The Nurochek-Pro System is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K231914 | Nurochek-II System / Headsafe MFG Pty Ltd. | ✓ |
The predicate device has not been subject to a design related recall.
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Image /page/5/Picture/0 description: The image shows the logo for "HEADSAFE". The logo consists of a green graphic on the left and the word "HEADSAFE" in bold, dark gray letters on the right. The graphic resembles a head in profile, with a gauge inside the head shape. The gauge is also green and has a needle pointing towards the right.
DEVICE DESCRIPTION
The Nurochek-Pro System is a portable system designed to generate visual evoked potentials (VEPs) in patients and acquire, transmit, display, and store the resulting electroencephalogram (EEG). It is intended for prescription use in healthcare facilities, by healthcare professionals, on subjects aged between 12 and 44 years old, to aid in the diagnosis of mild traumatic brain injury (mTBI). The primary components of the Nurochek-Pro System are the wearable headset, the Nurochek-Pro Software Application, and the Nurochek-Pro Server.
INDICATIONS FOR USE
The Nurochek-Pro System is intended for prescription use in healthcare facilities for subjects aged between 12 and 44 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment.
The Nurochek-Pro System is indicated for the generation of visual evoked potentials (VEP) and to acquire, transmit, display, and store electroencephalograms (EEG) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 12 and 44 years old who have sustained a potential head injury in the past 120 hours (5 days).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Headsafe believes that the Nurochek-Pro System is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a nearly identical design to the Nurochek-II System cleared in K231914. Both the subject and predicate device are worn on the head to record and analyze electroencephalograms (EEGs). They are both intended to aid in the diagnosis of mild traumatic brain injury (mTBI) through the analysis of these recorded EEGs. See below for a table comparing the device's technological characteristics.
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Image /page/6/Picture/0 description: The image shows the logo for HEADSAFE. The logo consists of a green graphic on the left and the word "HEADSAFE" in black on the right. The graphic on the left is a green gauge with a needle pointing to the right, and the bottom of the gauge is shaped like a head.
| Subject Device | Predicate Device | |
|---|---|---|
| HeadsafeNurochek-Pro SystemK243426 | HeadsafeNurochek-II SystemK231914 | |
| Indicationsfor Use | The Nurochek-Pro System is intended forprescription use in healthcare facilities forsubjects aged between 12 and 44 yearsold, for the aid in diagnosis of mildtraumatic brain injury (mTBI) inconjunction with a standard neurologicalassessment.The Nurochek-Pro System is indicated forthe generation of visual evoked potentials(VEPs) and to acquire, transmit, display,and store electroencephalograms (EEGs)during the generation of VEPs.Additionally, the system is indicated toanalyze captured EEG signals to providean aid in the diagnosis of mTBI in subjectsaged between 12 and 44 years old whohave sustained a potential head injury inthe past 120 hours (5 days). | The Nurochek-II System is intended forprescription use in healthcare facilities forsubjects aged between 16 and 46 yearsold, for the aid in diagnosis of mildtraumatic brain injury (mTBI) inconjunction with a standard neurologicalassessment.The Nurochek-II System is indicated for thegeneration of visual evoked potentials(VEPs) and to acquire, transmit, display,and store electroencephalograms (EEGs)during the generation of VEPs.Additionally, the system is indicated toanalyze captured EEG signals to provide anaid in the diagnosis of mild traumatic braininjury (mTBI) in subjects aged between 16and 46 years old who have sustained apotential head injury in the past 72 hours (3days). |
| Product Codes/ RegulationNumber | PIW / 21 CFR 882.1450OMC / 21 CFR 882.1400 | PIW / 21 CFR 882.1450OMC / 21 CFR 882.1400 |
| RegulationDescription | Brain injury adjunctive interpretiveelectroencephalograph assessment aid | Brain injury adjunctive interpretiveelectroencephalograph assessment aid |
| Components | Software in a Windows desktopapplication, reusable headset (LED lightsin front, EEG electrodes in back) | Software in a mobile application,reusable headset (LED lights in front, EEGelectrodes in back) |
| Power source | Mains power supply (via a USB-Aconnection to computer) | Rechargeable 3.7V lithium-ion battery |
| Inputs | Patient identifying information | Patient identifying information |
| ElectrodePlacement | Occipital lobe | Occipital lobe |
| ElectrodeChannels | Recording (3)Reference (1)Ground (1) | Recording (3)Reference (1)Ground (1) |
| SignalAmplification | Programmable gain amplifier (PGA)setting (same as predicate) | Programmable gain amplifier (PGA) |
| Subject Device | Predicate Device | |
| Headsafe | Headsafe | |
| Nurochek-Pro SystemK243426 | Nurochek-II SystemK231914 | |
| ConnectionHardware toSoftware | Wired connection (USB-A) | Wireless Connection (Bluetooth) |
| SoftwareInterface | Computer | Handheld device |
| Outputs | EEG Quality of electrode contact with patient Assessment of mTBI likelihood | EEG Quality of electrode contact with patient Assessment of mTBI likelihood |
| Data Analysis&CloudStorage | Records and stores EEGsCompares results to normative EEG data | Records and stores EEGsCompares results to normative EEG data |
| Patientinterface | Worn on patient's head for 2 minutes | Worn on patient's head for 2 minutes |
| Sterilization | Non-sterile | Non-sterile |
| Reuse | Headset is reusable(Silver-tipped rubber electrodes are reusable) | Headset is reusable(Foam cylinders for electrodes are single use only) |
| Sensitivity | 0.855195% confidence limits of (0.7496, 0.9283) | 0.860595% confidence intervals (0.7207, 0.9470) |
| Specificity | 0.670595% confidence limits of (0.5621, 0.7670) | 0.671695% confidence limits of (0.5460, 0.7815) |
| PatientPopulation | Subjects aged between 12 and 44 years old who have sustained a potential head injury in the past 120 hours (5 days) | Subjects aged between 16 and 46 years old who have sustained a potential head injury in the past 72 hours (3 days) |
| UseEnvironment | Healthcare facilities | Healthcare facilities |
| DeviceOperator | Healthcare professional | Healthcare professional |
| Subject Device | Predicate Device | |
| Headsafe | Headsafe | |
| Nurochek-Pro System | Nurochek-II System | |
| K243426 | K231914 | |
| Sensitivity % [95% CI] | 85.51 [74.96-92.83] | 86.05 [72.07-94.70] |
| Specificity % [95% CI] | 67.05 [56.21-76.70] | 67.16 [54.60-78.15] |
| #Patients Clinically Diagnosed as Concussed | 69 | 43 |
| #Patients Clinically Diagnosed as Not Concussed | 88 | 67 |
| Prevalence of mTBI in Validation Study % | 43.9 | 39.1 |
| Positive Predictive Value (PPV) % | 67.0 | 62.7 |
| Negative Predictive Value (NPV) % | 85.5 | 88.2 |
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Image /page/7/Picture/0 description: The image shows the logo for Headsafe. The logo consists of a green icon that resembles a gauge and a stylized head, followed by the word "HEADSAFE" in bold, dark gray letters. The gauge icon has a needle pointing towards the right, and the head shape is formed by the bottom part of the gauge.
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Image /page/8/Picture/0 description: The image shows the logo for Headsafe. The logo consists of a green graphic on the left and the word "HEADSAFE" in black on the right. The graphic is a stylized head with a gauge inside, suggesting safety or measurement. The text is in a bold, sans-serif font, making it easily readable.
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Nurochek-Pro System. The following tests were performed to demonstrate safety based on current industry standards:
Biocompatibility:
The subject device was evaluated for cytotoxicity, sensitization, and irritation in compliance to ISO10993-5:2009 and ISO 10993-10:2010.
Software Verification:
The software development and testing were executed with consideration to IEC 62304.
Electromagnetic Compatibility and Electrical Safety:
The subject device was tested in compliance to IEC 60601-1:2012. IEC 60601-1-2:2014. IEC 60601-2-40:2016.
SUMMARY OF CLINICAL TESTING
The primary objective of the clinical investigation was to evaluate the performance of the Nurochek-Pro System against clinical diagnosis by a licensed healthcare professional in the accurate detection of mild traumatic brain injury (mTBI). The study demonstrated that the device can differentiate between subjects with and without mTBI.
The Headsafe classification Algorithm used in this device was generated with 272 individual steady-state visual-evoked potential (SSVEP) readings, in which there was a 24.6% prevalence of mTBI. The SSVEP readings from the study subjects (age range 12-49 years) were used to generate the database, to which the device compares new results. The clinical research protocol required readings to be collected within 120 hours of the suspected head injury, in addition to a clinical evaluation by a licensed physician. Each highly trained physician used their education and experience to deliver their mTBI determination. At the core of each assessment was a neurological examination, a concussion-related signs and symptom evaluation, and a review of all relevant information provided by the study subject in relation to their injury. A separate validation dataset consisting of 157 individual SSVEP readings, in which there was a 43.9% prevalence of mTBI in the population, resulted in a sensitivity of 85.51% (74.96-92.83. 95% confidence interval) and a specificity of 67.05% (56.21-76.70, 95% confidence interval). The resulting Positive Predictive Value (PPV) and Negative Predictive Value (NPV) were 67.0% and 85.5%, respectively.
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Image /page/9/Picture/0 description: The image shows the logo for HEADSAFE. The logo consists of a green graphic on the left and the word "HEADSAFE" in bold, dark gray letters on the right. The graphic on the left is a stylized head with a gauge inside, suggesting a focus on head safety or protection.
CONCLUSION
Based on the testing performed, it can be concluded that the subject device does not raise different questions of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Nurochek-Pro System are assessed to be substantially equivalent to the predicate device.
§ 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.
(a)
Identification. A brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:
(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.
(ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.
(2) The device parts that contact the patient must be demonstrated to be biocompatible.
(3) The device must be designed and tested for electrical safety, electromagnetic compatibility (EMC), thermal, and mechanical safety.
(4) Clinical performance testing must demonstrate the accuracy, precision-repeatability and reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs).
(5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with respect to the study prevalence per the device intended use.
(6) The device design must include safeguards to ensure appropriate clinical interpretation of the device output (
e.g., use in appropriate patient population, or for appropriate clinical decision).(7) The labeling and training information must include:
(i) A warning that the device is not to be used as a stand-alone diagnostic.
(ii) A detailed summary of the clinical performance testing, including any adverse events and complications.
(iii) The intended use population and the intended use environment.
(iv) Any instructions technicians should convey to patients regarding the collection of EEG data.
(v) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway.
(vi) Information allowing clinicians to understand how to integrate the device output into their diagnostic pathway when the device is unable to provide a classification or final result.